This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....
This communication is issued in view that SAHPRA has embarked on a process to digitalise its business processes and need to pilot the electronic process. The pilot is planned for new medicinal clinical applications for the month of October 2025, with the official launch of...
This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....
This communication is issued given the current uncertainty about US government funding for healthcare in South Africa, particularly in clinical research, and it intends to emphasise the responsibilities of various stakeholders in Clinical Trials....
This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all applicants/Holders of Certificates of Registration (HCRs) who intend to submit/have submitted applications supported by bioequivalence studies conducted by Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located...
This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines. Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...
This communication is for Stakeholders to be aware of SAHPRA's Clinical Trials Committee meeting dates and the submission dates for the year of 2025. ...
This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....
This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines. The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...